FDA.reportPublic FDA data

Dr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30

Manufacturer
Cosmetic Solutions LLC
Effective date
2023-01-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:23

Label at a glance#

ProductDr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30
Active ingredientZinc Oxide
Label structure10 sections

Indications and uses

Helps prevent sunburn If used as directed with other sun protection measures (see Directions ) decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure Children under 6 months of age: ask a doctor Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures i...

Storage and handling

Protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 16%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Children under 6 months of age: ask a doctor
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

STORAGE AND HANDLING SECTION

  • Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Butyloctyl Salicylate, Dimethicone, Caprylic/Capric Triglyceride, Glycerin, Coconut Alkanes, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Vaccinium Vitis-Idaea (Lingonberry) Fruit Extract, Ferulic Acid, Hippophae Rhamnoides (Sea Buckthorn) Fruit Extract, Arctostaphylos Uva-Ursi (Bearberry) Leaf Extract, Aloe Barbadensis Leaf Juice, Quercetin, Tocopherol, Tocopheryl Acetate, Xanthophylls (Lutein), Sucrose, Ethylhexylglycerin, Lecithin, Polyglutamic Acid, Tapioca Starch, Calcium Gluconate, Dimethicone/Polyglycerin-3 Crosspolymer, Triheptanoin, Xanthan Gum, Polyhydroxystearic Acid, Coco-Caprylate/Caprate, Triethoxycaprylylsilane, Polymethylsilsesquioxane, Propanediol, C13-15 Alkane, Dipropylene Glycol, Sodium Hydroxide, Disteardimonium Hectorite, Isostearyl Lactate, Triethyl Citrate, Sodium Chloride, Tetrasodium Glutamate Diacetate, Gluconolactone, Sodium Citrate, Citric Acid, Phenoxyethanol, Sodium Benzoate, Potassium Sorbate

Questions?

OTC - QUESTIONS SECTION

Call 1-888-830-7546
Monday through Friday, 9:00 AM to 5:00 PM EST

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr Dennis Gross

All-Physical

Lightweight
Wrinkle Defense

Broad Spectrum
Sunscreen SPF 30

Oil-Free / Reef Safe

You want: Defense against
harmful sun damage

1.7 fl oz/50ml ℮

Principal Display Panel - 50 ml Tube Carton
Principal Display Panel - 50 ml Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
124351b2-6dbf-42d0-9ea7-f0e299215f9aProduct name120210115

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-4272-12025-01-30C16284748780-12cef2736-7459-d83d-e063-dadaa90ab31fDr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30
66163-4272-22025-01-30C16284748780-12cef2736-7459-d83d-e063-dadaa90ab31fDr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30
66163-4272-32025-01-30C16284748780-12cef2736-7459-d83d-e063-dadaa90ab31fDr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30
66163-4272-42025-01-30C16284748780-12cef2736-7459-d83d-e063-dadaa90ab31fDr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-4272-1Dr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 3015 mL in 1 TUBELIQUID152
66163-4272-2Dr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 3030 mL in 1 TUBELIQUID302
66163-4272-3Dr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 3050 mL in 1 TUBELIQUID502
66163-4272-4Dr. Dennis Gross Skincare - Lightweight Wrinkle Defense Broad Spectrum SPF 307 mL in 1 TUBELIQUID72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-4272DR. DENNIS GROSS SKINCARE - LIGHTWEIGHT WRINKLE DEFENSE BROAD SPECTRUM SPF 30 (ZINC OXIDE) LIQUID [COSMETIC SOLUTIONS LLC]2Legacy NDC, 4 package rows20230121_88ffd3bf-9f4e-4775-b161-acd186c5f228.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-427266163-4272-1, 66163-4272-2, 66163-4272-3, 66163-4272-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Dimethicone92RU3N3Y1OIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
GlycerinPDC6A3C0OXIACT
Coconut Alkanes1E5KJY107TIACT
Lingonberry0UNK9RZQ7XIACT
Ferulic AcidAVM951ZWSTIACT
Aloe Vera LeafZY81Z83H0XIACT
Quercetin9IKM0I5T1EIACT
TocopherolR0ZB2556P8IACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
LuteinX72A60C9MTIACT
Starch, Tapioca24SC3U704IIACT
Calcium GluconateSQE6VB453KIACT
Triheptanoin2P6O7CFW5KIACT
Xanthan GumTTV12P4NEEIACT
Cocoyl Caprylocaprate8D9H4QU99HIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Polymethylsilsesquioxane (4.5 Microns)59Z907ZB69IACT
Propanediol5965N8W85TIACT
C13-15 Alkane114P5I43UJIACT
Dipropylene GlycolE107L85C40IACT
Sodium Hydroxide55X04QC32IIACT
Disteardimonium HectoriteX687XDK09LIACT
Isostearyl Lactate8OM3O3YPMLIACT
Triethyl Citrate8Z96QXD6UMIACT
Sodium Chloride451W47IQ8XIACT
Tetrasodium Glutamate Diacetate5EHL50I4MYIACT
GluconolactoneWQ29KQ9POTIACT
Sodium Citrate, Unspecified Form1Q73Q2JULRIACT
Citric Acid Monohydrate2968PHW8QPIACT
PhenoxyethanolHIE492ZZ3TIACT
Sodium BenzoateOJ245FE5EUIACT
Potassium Sorbate1VPU26JZZ4IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5313aba4-617b-4f61-9eba-1c8c06a3934b88ffd3bf-9f4e-4775-b161-acd186c5f2282023-01-19WarningsExact identifier
spl id: 5313aba4-617b-4f61-9eba-1c8c06a3934b
spl set id: 88ffd3bf-9f4e-4775-b161-acd186c5f228

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.